Automated World Health
L28842
FLUDARABINE (FLUDARA®)
02/02/2009
Indications and Limitations of Coverage and/or Medical Necessity
Fludarabine (Fludara®)-J9185
• Fludarabine is FDA approved for treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
• Medicare will cover Fludarabine for its FDA approved uses, as well as for the treatment of the following off-labeled indications:
o Acute Non-Lymphocytic Leukemia.
o Non-Hodgkin’s Lymphoma.
o Waldenstrom’s Macroglobulinemia.
o First-line treatment of chronic lymphocytic leukemia.
Coding Information
Bill Type Codes
• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.
• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.
• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
13x Hospital Outpatient
21x Skilled Nursing - Inpatient (Including Medicare Part A)
22x Skilled Nursing - Inpatient (Medicare Part B only)
23x Skilled Nursing - Outpatient
85x Critical Access Hospital
Revenue Codes
• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.
• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.
• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
CPT/HCPCS Codes
J9185 INJECTION, FLUDARABINE PHOSPHATE, 50 MG
ICD-9 Codes that Support Medical Necessity
200.00 RETICULOSARCOMA UNSPECIFIED SITE
200.01 RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.02 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.03 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.04 RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.05 RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.06 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.07 RETICULOSARCOMA INVOLVING SPLEEN
200.08 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.10 LYMPHOSARCOMA UNSPECIFIED SITE
200.11 LYMPHOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.12 LYMPHOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.13 LYMPHOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.14 LYMPHOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.15 LYMPHOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.16 LYMPHOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.17 LYMPHOSARCOMA INVOLVING SPLEEN
200.18 LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.20 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE
200.21 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.22 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES
200.23 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.24 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.25 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.26 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES
200.27 BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN
200.28 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.30 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.31 MARGINAL ZONE LYMPHOMA,LYMPH NODES OF HEAD, FACE, AND NECK
200.32 MARGINAL ZONE LYMPHOMA,INTRATHORACIC LYMPH NODES
200.33 MARGINAL ZONE LYMPHOMA, INTRAABDOMINAL LYMPH NODES
200.34 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.35 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.36 MARGINAL ZONE LYMPHOMA, INTRAPELVIC LYMPH NODES
200.37 MARGINAL ZONE LYMPHOMA, SPLEEN
200.38 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.47 MANTLE CELL LYMPHOMA, SPLEEN
200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.50 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.51 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.52 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRATHORACIC LYMPH NODES
200.53 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.54 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.55 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.56 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRAPELVIC LYMPH NODES
200.57 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, SPLEEN
200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.60 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.61 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.62 ANAPLASTIC LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.63 ANAPLASTIC LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.64 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.65 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.66 ANAPLASTIC LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.67 ANAPLASTIC LARGE CELL LYMPHOMA, SPLEEN
200.68 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
200.75 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
200.77 LARGE CELL LYMPHOMA, SPLEEN
200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.80 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE
200.81 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
200.82 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES
200.83 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
200.84 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
200.85 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
200.86 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES
200.87 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING SPLEEN
200.88 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 NODULAR LYMPHOMA UNSPECIFIED SITE
202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES
202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES
202.07 NODULAR LYMPHOMA INVOLVING SPLEEN
202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.10 MYCOSIS FUNGOIDES UNSPECIFIED SITE
202.11 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.12 MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES
202.13 MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.14 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.15 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.16 MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES
202.17 MYCOSIS FUNGOIDES INVOLVING SPLEEN
202.18 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES
202.20 SEZARY'S DISEASE UNSPECIFIED SITE
202.21 SEZARY'S DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.22 SEZARY'S DISEASE INVOLVING INTRATHORACIC LYMPH NODES
202.23 SEZARY'S DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.24 SEZARY'S DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.25 SEZARY'S DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.26 SEZARY'S DISEASE INVOLVING INTRAPELVIC LYMPH NODES
202.27 SEZARY'S DISEASE INVOLVING SPLEEN
202.28 SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.30 MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE
202.31 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.32 MALIGNANT HISTIOCYTOSIS INVOLVING INTRATHORACIC LYMPH NODES
202.33 MALIGNANT HISTIOCYTOSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.34 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.35 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.36 MALIGNANT HISTIOCYTOSIS INVOLVING INTRAPELVIC LYMPH NODES
202.37 MALIGNANT HISTIOCYTOSIS INVOLVING SPLEEN
202.38 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.40 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE
202.41 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.42 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRATHORACIC LYMPH NODES
202.43 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.44 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER ARM
202.45 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.46 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRAPELVIC LYMPH NODES
202.47 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING SPLEEN
202.48 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.50 LETTERER-SIWE DISEASE UNSPECIFIED SITE
202.51 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.52 LETTERER-SIWE DISEASE INVOLVING INTRATHORACIC LYMPH NODES
202.53 LETTERER-SIWE DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.54 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.55 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.56 LETTERER-SIWE DISEASE INVOLVING INTRAPELVIC LYMPH NODES
202.57 LETTERER-SIWE DISEASE INVOLVING SPLEEN
202.58 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.60 MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE
202.61 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.62 MALIGNANT MAST CELL TUMORS INVOLVING INTRATHORACIC LYMPH NODES
202.63 MALIGNANT MAST CELL TUMORS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.64 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.65 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.66 MALIGNANT MAST CELL TUMORS INVOLVING INTRAPELVIC LYMPH NODES
202.67 MALIGNANT MAST CELL TUMORS INVOLVING SPLEEN
202.68 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.70 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
202.71 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
202.74 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
202.75 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN
202.78 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE
202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES
202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES
202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN
202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.90 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE
202.91 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.92 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRATHORACIC LYMPH NODES
202.93 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.94 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.95 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.96 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRAPELVIC LYMPH NODES
202.97 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING SPLEEN
202.98 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES
204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION
204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE
204.90 UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
204.91 UNSPECIFIED LYMPHOID LEUKEMIA IN REMISSION
204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE
205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
205.01 MYELOID LEUKEMIA ACUTE IN REMISSION
205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE
206.00 ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
206.01 MONOCYTIC LEUKEMIA ACUTE IN REMISSION
206.02 ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE
207.00 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
207.01 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA IN REMISSION
207.02 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE
273.3 MACROGLOBULINEMIA
Diagnoses that Support Medical Necessity
See ICD-9 Codes that Support Medical Necessity
Documentation Requirements
• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.
o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.
o This documentation is usually found in the history and physical or in the office/progress notes.
• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.
o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.
Treatment Logic
• Fludarabine phosphate is a nucleotide analog which is incorporated into DNA and inhibits further DNA synthesis.
• Fludarabine is FDA approved for treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
Sources of Information and Basis for Decision
Compendia-Based Drug Bulletin. (May 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.
FCSO LCD 29176, Fludarabine (Fludara®), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
National Cancer Institute. (2006). Leukemia, chronic lymphocytic: Treatment-Health Professional Information [NCI PDQ]. [On-Line]. Retrieved March 8, 2007, from http://www.webmd.com/cancer
Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch
U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, July 2007.
AMA CPT Copyright Statement
CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.
© Automated Clinical Guidelines, LLC 2009-2013